Digital IT Operations_GxP Compliance _ Computer System Validation

IT Operations & Compliance Leadership

NAGESWAR RAO

Email: ************@*****.*** Mob: +91-989**-***** 799**-*****

LinkedIn: www.linkedin.com/in/nageswar-rao-pedini-9244b878 PROFESSIONAL SUMMARY:

Seasoned IT leader with 16 years of experience in infrastructure management, digital transformation, GxP compliance, and Computer System Validation Support across regulated manufacturing environments. Proven expertise in ensuring business continuity, service reliability, and cybersecurity resilience. Skilled in datacentre management, network security, disaster recovery, and enterprise applications including SAP, ERP, LIMS, and TrackWise QMS. Recognized for successfully recovery major cyber-attack & leading ERP, QR Code, Serialization rollouts, PLC SACADA, laboratory modernization, and audit readiness under FDA and global regulatory inspections.

SKILLS:

Infrastructure Management IT Operations Leadership Digital Transformation IT Budgeting (CAPEX/OPEX) GxP Compliance Computer System Validation (CSV) Business Continuity & Disaster Recovery Service Reliability Cybersecurity resilience Datacentre Management Network Security VMware & Windows Server Administration Active Directory & Microsoft 365 Network & Firewall Administration Backup & Storage Management FDA / MHRA / Global Audit Readiness IT/OT Security Vendor & SLA Management IT Governance & SOP Implementation IT Service Management (ITSM) Risk Management Team Leadership & Stakeholder Management Enterprise Applications SAP, TrackWise QMS, LIMS. PROFESSIONAL EXPERIENCE:

Sr. Technical Lead – Infrastructure (Cluster Lead) Strides Pharma Science Ltd. (via Coforge Ltd), Bengaluru Oct 2025 – Present

Directed IT infrastructure operations across manufacturing sites, ensuring uninterrupted business continuity, service availability, reliability, and security.

Oversaw infrastructure and GxP compliance including digital transformation, QMS activities, ITSM Ticket SLAs, Periodic tasks, audit support, IT projects, and CSV support.

Managed servers, backups, storage, and networking; led OS/firmware upgrades, patch management, and preventive maintenance.

Managed IT budgets, AMC renewals, license management, and asset procurement to optimize cost efficiency and resource utilization.

Participated in daily review calls (site-level and corporate), and Quality Review Board meetings aligning IT services with compliance requirements, and business priorities.

Managed GxP system administration: user access management, backups, audit trail verification, electronic data checks, time synchronization, PM and breakdown support.

Prepared and submitted weekly/monthly MIS report ensuring transparency and performance tracking.

Mentored IT team and cross-functional teams to foster collaboration, compliance awareness and continuous improvement.

Unit Lead – IT

Dr. Reddy’s Laboratories (via Fidelies), Vizag Mar 2025 – Sep 2025

Manager – IT

Sun Pharma Laboratories Ltd., Guwahati Dec 2022 – Feb 2025

Asst. Manager – IT

Ajanta Pharma Ltd., Bharuch Oct 2021 – Sep 2022

Sr. Executive – IT

Cadila Pharmaceuticals Pvt. Ltd., Ahmedabad Oct 2019 – Sep 2021

Executive – IT

Concord Biotech Ltd., Ahmedabad May 2018 – Oct 2019

IT Operations Analyst

Zydus Cadila Healthcare Ltd. (via Accenture Services), Ahmedabad Dec 2015 – May 2018

System Admin

Accel Frontline Ltd., Mumbai Jul 2012 – Dec 2015

EDUCATION:

MBA Grade - A Grade 2023

IITMS (Imperial Institute of Technical & Management Studies) B. Com Class - Second Class 2011

Mumbai University

H.S.C Class - Pass Class 2005

Pune University

S.S.C Class - Second Class 2003

Cuttack University

CERTIFICATIONS & TRAINING:

Microsoft MCITP Red Hat Administration Cisco CCNA Computer System Validation (CSV) Computer Software Assurance (CSA) Hardware & Networking Teacher Training. ACHIEVEMENTS:

Successfully managed recovery from a major cyber-attack, Resolved global CrowdStrike BSOD issue, Awarded Best Support & Performance Recognition (Regional level), Supported multiple FDA (including surprise inspections) and global audits with commendations for compliance readiness and issue resolution. CONTINUE IMPROVEMENT: Process Excellence

Actively participated in Process improvement programs like; IFQM, Quality Circles, Gemba walks, Outbound and Kaizen and drove quality-driven IT practices and fostered collaboration with plant team. PROJECT EXPERIENCE:

Infrastructure & Security

Enforced VMware ESXi upgrades, OS patching, antivirus updates, firmware updates and preventive maintenance to minimize downtime.

Strengthened cybersecurity posture with FireEye, CrowdStrike, DLP, and Trend Micro, reducing vulnerabilities and enhancing endpoint protection.

Implemented security hardening measures: removal of generic IDs, deployment of LAPS, ignio tool, USB restrictions, Wi-Fi SSID hardening, and access monitoring.

Digital Transformation & Projects

Rolled out corporate IT policies and GSOPs at site level, standardizing compliance practices.

Implemented Office 365, Track & Trace, ERP, Abacube Cloud, QR code systems.

Integrated IT/OT network for PLC/SCADA systems, enabling secure manufacturing connectivity.

Deployed E-Log systems, Werum PAS-X EBR (Sarala), Early Warning System (EY), and upgraded laboratory platforms.

Validated Laboratory & Manufacturing equipment’s, GSOP preparation, documents reviewed & approved, conducted vendor audits, involving on FAT discussions, Vendor discussion.

Rolled out compliance tools: Paperless initiatives, CMDB, Medhas, ITSM, EDMS, Val Genesis VLMS, Leucine e-Log, Syncade eBMR, Compliance Wire LMS, SharePoint, DMS, NVR-based CCTV surveillance. LANGUAGES:

English Hindi Oriya Telugu Marathi Gujarati

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